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EU’s Pharma Package falls short of Europe’s goal of global competitiveness

Pharmaceutical Technology

Further, they say the balance attempted between encouraging innovation and improving access instead could be contradictory for drug developers and investors, in a way that is emblematic of a fragmented EU. Industry reactions have been mixed.

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Organon drug for endometriosis falls short in mid-stage study

BioPharma Dive

Chief Executive Kevin Ali called the drug a “multibillion dollar opportunity” during the J.P. The company had hoped to kick off Phase 3 research in 2026 and launch the medicine around 2029. Organon acquired the drug in its purchase of Forendo Pharma in 2021. Morgan Healthcare Conference in January.

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Vor Bio back from brink with autoimmune drug deal rising to $4bn

Pharmaceutical Technology

A month and a half after winding operations and laying off almost all its staff, Vor Bio has emerged from the brink with a licensing deal potentially rising to $4bn for an autoimmune drug developed by Chinese biotech RemeGen. GlobalData is the parent company of Pharmaceutical Technology.

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WHO endorses Gilead’s Yeztugo for HIV prevention

Pharmaceutical Technology

A report by UNAIDS predicts that six million new HIV infections and four million AIDS-related deaths could occur between 2025 and 2029 if US-supported HIV treatment and prevention services collapse.

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The Sun Has Started to Set on the Rare Pediatric Disease Priority Review Voucher Program – But It Can Still be Saved

FDA Law Blog: Biosimilars

Earlier in the week, it was reported that there was a bipartisan agreement on a bill that would have funded the government and extended the first sunset date for the rare pediatric disease priority review voucher program for nearly 5 years, until September 30, 2029.

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EHDS regulation will depend on strong patient confidence

Pharmaceutical Technology

The regulation came into force in March 2025; however, it has not yet come into application, with this set to happen in March 2029. Experts also emphasised that the secondary data will help with accelerating drug development cycles, making clinical trials more cost-efficient, and improving real-world insights.

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

It is extremely difficult, if not impossible, to do the long-term planning and substantial fundraising required for drug development without knowing whether such an important and valuable incentive will be there. We heard and felt the anxiety from many of our clients about the uncertainty this caused.